A Clinical Pharmacokinetics Comparing Brand and Generic Topiramate in Epilepsy Patients : A Open-label,Randomised, Three-period Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To Measure the Area under the plasma concentration versus time curve, serum trough drug level of generic and brand topiramate through pharmacokinetics study.
研究概览
简要总结
The purpose of the study is to prove the bioequivalence of brand and generic topiramate.
详细描述
Generic antiepileptic drugs (AED) achieve blood concentration similar to the brand AED. However, controversies exist about efficacy and safety of substituting generic AEDs. Because even minor absorption and kinetic differences can elicit a breakthrough seizure in patients who are changed to a generic AED from brand AED. Therefore, more ideal evaluation of interchangeability from the brand AEDs to generic formulation of the same drug is three-way or four-way crossover study, which can evaluate within-subject variability in pharmacokinetic and pharmacodynamic. Investigator designed four-way crossover study aimed to assess bioequivalence of brand and generic topiramate, to measure trough serum level , and to evaluate efficacy, tolerability and side effect of generic topiramate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-65 years
- •Patients with epilepsy who take by topamax 100mg bid or who need to take topamax 100mg bid
排除标准
- •poor compliance
- •subjects whose dose of antiepileptic drug are changed during the study
- •subjects whose seizure is not well-controlled judged by neurologist
- •history of any kind of drug allergy
- •pregnancy or nursing
- •existing or recent significant disease (cardiac, hepatic, or renal disease, severe diabetes mellitus, sepsis, etc.)
研究组 & 干预措施
Pharmacokinetic study, topamed
For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in first visit day.
For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in second visit day.
For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in third visit day.
For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in third visit day.
干预措施: Pharmacokinetic study (Procedure)
Pharmacokinetic study, topamax
For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in first visit day.
For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in second visit day.
For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in third visit day.
For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in third visit day.
干预措施: Pharmacokinetic study (Procedure)
结局指标
主要结局
To Measure the Area under the plasma concentration versus time curve, serum trough drug level of generic and brand topiramate through pharmacokinetics study.
时间窗: [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after taking the brand or generic topiramate during 7 days]
All comparisons of the drug formulations fulfill the bioequivalence criteria, with all 90% Confidential intervals(CIs) for Cmax, AUC, and Ctrough being within the 80-125% acceptance range. Scaling average bioequivalence that the acceptable bioequivalence limits of 90% CI of generic to brand topiramate will be those limits that are within and/or similar to the bioequivalence limits of the 90% CI of Brand to Brand topiramate
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of generic topiramate in subjects with epilepsy(4weeks)
研究者
Kon Chu
MD,PhD, professor
Seoul National University Hospital